SUPPLY CHAIN ARTICLES

  • The mRNA Supply Chain Revolution: Materials, Methods, And Momentum

    mRNA innovation now hinges as much on manufacturing materials as on molecular design, with novel inputs shaping performance, cost, and scalability. As these less-mature materials move rapidly into production, strategic material selection and supplier alignment are becoming critical to manufacturing resilience and long-term success.

  • From Misinformation To Medicine: Forging Bipartisan Support to Reverse Anti-mRNA Policy

    In this article, I’ll share some of the progress AMM has made and the barriers the organization/our industry is still facing in our efforts to reverse the policy decisions that have been made against mRNA today. Throughout the panel, the speakers also shared their thoughts on the types of messaging we should be considering and/or have started to see making an impact. 

  • Multidisciplinary mRNA: What Can We Learn From Other CGTs?

    Overall, there are four high-level best practices/mindsets I proposed during a recent presentation that I believe will be crucial for us to bring some talented RNA therapeutic role models to the forefront. But there is one best practice that I think is worth emphasizing more than the others.

  • Biomanufacturing Capacity Crunch: It's The Supply Chain's Fault

    What's behind the protracted biopharma manufacturing capacity crunch, when will it end, and what are manufacturers doing to keep supply on track? During Biotech Week in Boston ad BioProcess International, CDMOs and sponsors weighed in.

  • Inside Alnylam's Playbook For High Volume siRNA Production

    As one of the first companies to establish a chemoenzymatic ligation platform, Alnylam's Maines and Nechev are in the perfect position to espouse wisdom on the practical aspects and remaining challenges of implementing enzymatic ligation at a large scale. Here in this installment, Maines and Nechev outline what they’ve learned thus far about the science of enzymatic ligation, while also paying credence to the unknowns and existing barriers that, as a frontrunner, Alnylam will inevitably (but willingly) be tasked with facing in the future.

  • FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities

    The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.

SUPPLY CHAIN VIDEOS

The mRNA supply chain is undergoing massive growth in three particular areas. Here, speakers Khaled Yamout & Francoise Ribes walk us through the materials that have undergone the most scientific growth over the past few years and the impacts they’re noting these advancements having on the development of our mRNA drug substances and mRNA-LNP drug products. 

In this Advancing RNA Live segment, several speakers raise concerns about the industry's ability to accurately measure impurities, particularly dsRNA, arguing that current analytics are insufficient, especially for high-dose therapeutics.

Together, this Advancing RNA panel briefly addresses the ongoing rise of synthetic pDNA, sharing the current benefits and limitations of working with this technology for plasmid production today.

While we can make lots of mRNA at a smaller scale, when it comes to scaling up to kg quantities of mRNA, our current batch processes leave a lot to be desired. Together, Stu Sundseth of Tune Therapeutics and Christian Dohmen of Ethris unpack the biggest barriers to scaling IVT to achieve the desired yield and quality of mRNA, offering their take on how the field is innovating to overcome these issues. 

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS